Improvement of Personalized Lung Cancer Care Through Digital Connection and Patient Participation (DigiNet)
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Interventions
- Other: DigiNet intervention
- Registration Number
- NCT05818449
- Lead Sponsor
- University of Cologne
- Brief Summary
The aim of the DigiNet project is to improve the treatment of patients with advanced non-small cell lung cancer (NSCLC) in Germany. The project promotes the transfer of the latest scientific knowledge into standard care. The DigiNet project is based on the established precision medicine program, the National Network Genomic Medicine Lung Cancer (nNGM) in Germany, whereby every patient receives molecular diagnostics and personalized therapy information after the initial diagnosis. Within the framework of the DigiNet project, specialized academic centers will be digitally connected with practitioners via a shared project database. Furthermore, a committee of experts will monitor the course of treatment and will advise the practitioners in case of critical conditions. Additionally, patient-reported outcomes will be incorporated into the treatment.
- Detailed Description
The aim of the DigiNet project is to prospectively evaluate a precision medicine program for lung cancer and to improve personalized care of patients with advanced non-small cell lung cancer (NSCLC) through a collaboration of specialized academic centers with routine care providers (hospitals, oncology practices). The use of targeted therapies will be regularly monitored and guided through a shared digital database. Patients with an initial diagnosis of stage IV NSCLC in the study regions (study region east: Berlin and Saxony; study region west: North Rhine-Westphalia) are included. DigiNet builds on the foundations and structures of the National Network Genomic Medicine Lung Cancer (nNGM) in Germany, which provides molecular diagnostics and treatment information to the participating physicians based on the latest evidence.
Within the framework of DigiNet, patients are regularly consulted by the study practitioners and the clinical data is documented in a structured manner in a central project database. Through the digital collaboration of the nNGM network centers via the shared project database with the practitioners in routine care, continuous monitoring of the course of treatment and, in the case of critical conditions, treatment guidance by an expert committee advising the practitioner is provided. In addition, the patients routinely assess the quality of life (EORTC QLQ-C30, EORTC QLQ-LC29, EQ-5D), as well as anxiety and depression (PHQ-4). The results of these patient-reported outcomes (PROs) are incorporated into the treatment by the practitioners (patient-centered treatment approach).
The evaluation of the project is structured into different core domains: An evaluation of clinical endpoints, process parameters (implementation of the intervention), and health economic evaluations will be conducted. The acceptance and potential for improvement of the project will be assessed through qualitative interviews with the stakeholders. Data from the state cancer registries of the study regions will be incorporated to generate a population-based comparative cohort for the evaluation of the main research questions of DigiNet, thereby representing patients receiving routine care in Germany.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 850
- Patients diagnosed with advanced NSCLC, stage IV
- Age > 18 years
- Life expectancy at least 4 weeks (initial assessment at inclusion in nNGM and confirmation at baseline (implementation of treatment decision))
- Missing informed consent
- Illnesses and behaviors that impair compliance (e.g., dementia, addictive disorders)
- Severely impaired general physical condition that no longer permits therapy for lung cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DigiNet group DigiNet intervention The intervention group will receive the DigiNet intervention.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) up to 34 months Overall Survival (OS) will be assessed in months.
- Secondary Outcome Measures
Name Time Method Frequency of patients' completing the PROs up to 34 months Assessing the frequency of patients' completing the patient-reported outcomes (PRO) via the internet portal
Progression-Free Survival (PFS) up to 34 months Progression-Free Survival (PFS) will be assessed in months.
Hospitalization rate up to 34 months Frequency of hospital stays will be assessed using health insurance data.
Quality of Life (EORTC QLQ-C30) up to 34 months Quality of Life (European Organisation for Research and Treatment of Cancer, Quality of Life Core Questionnaire, EORTC QLQ-C30) will be assessed in absolute values and change over time. Each item is rated on a response scale 1 = "not at all" to 4 = "very much" with exception of the last two items, which assess overall health and quality of life on a scale from 1 = "very poor" to 7 = "excellent". All EORTC QLQ-C30 scale scores range from 0 to 100, whereby higher scores on a functional scale indicate a high level of functioning, whereas higher scores on a symptom scale/symptom item indicate greater symptom burden.
Symptoms of anxiety (GAD-2) up to 34 months Symptoms of anxiety (Generalized Anxiety Disorder Scale-2, GAD-2) will be assessed in absolute values and change over time. Each item is rated on a response scale 0 = "not at all" to 3 = "nearly every day" and refer to the time frame "during the past two weeks". Higher scores indicate greater symptom burden.
Symptoms of depression (PHQ-2) up to 34 months Symptoms of depression (Patient-Health-Questionnaire-2, PHQ-2) will be assessed in absolute values and change over time. Each item is rated on a response scale 0 = "not at all" to 3 = "nearly every day" and refer to the time frame "during the past two weeks". Higher scores indicate greater symptom burden.
Frequency of applied targeted molecular therapies based on clinical therapy information from the MURIEL database up to 34 months The frequency of applied targeted molecular therapies is based on clinical therapy information from the MURIEL database.
Cost of implementation related to DigiNet from the service provider perspective (hospital, practices) up to 34 months Assessing the cost of implementation related to DigiNet from the service provider perspective (hospital, practices) in Euro (€)
Time on First Treatment (ToT) up to 34 months Duration under first-line therapy will be assessed in months.
Frequency of active contact of the expert advisory board with physicians during the course of treatment up to 34 months Assessing the frequency of the expert advisory board actively contacting physicians during the course of treatment
Completeness of the documentation of the treatment course up to 34 months Assessing the completeness of the documentation of the treatment course (DigiNet study visits) in %.
Quality of Life (EORTC QLQ-LC29) up to 34 months Quality of Life (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer, EORTC QLQ-LC29) will be assessed in absolute values and change over time. Each item is rated on a response scale 1 = "not at all" to 4 = "very much" and refer to the time frame "during the past week". All EORTC QLQ-LC29 scale scores range from 0 to 100, whereby higher scores for a symptom scale/symptom item indicate greater symptom burden.
Cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained up to 34 months Assessing the cost-effectiveness of DigiNet compared to standard care in terms of incremental costs per life years gained
Cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year [QALY] up to 34 months Assessing the cost-effectiveness of DigiNet compared to standard care in terms of costs per quality-adjusted life year \[QALY\]
Formative evaluation up to 34 months Formative evaluation regarding the implementation will be conducted using qualitative analysis of semi-structured interviews
Process costs related to DigiNet from the service provider perspective (hospital, practices) up to 34 months Assessing the process costs related to DigiNet from the service provider perspective (hospital, practices) in Euro (€)
Trial Locations
- Locations (41)
Klinikum Leverkusen
🇩🇪Leverkusen, NRW, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Bayern, Germany
Universitätsklinikum Aachen
🇩🇪Aachen, NRW, Germany
Universitätsklinikum Köln
🇩🇪Köln, NRW, Germany
Hämatologisch-Onkologische Schwerpunktpraxis
🇩🇪Bad Liebenwerda, Brandenburg, Germany
Onkozentrum Bonn
🇩🇪Bonn, NRW, Germany
Universitätsklinikum Bonn (UKB)
🇩🇪Bonn, NRW, Germany
Zentrum für ambulante Hämatologie und Onkologie Rhein-Sieg (ZAHO)
🇩🇪Brühl, NRW, Germany
Johanniter-Krankenhaus Bonn
🇩🇪Bonn, NRW, Germany
Gemeinschaftspraxis für Hämatologie & Onkologie
🇩🇪Dortmund, NRW, Germany
Praxis für Hämatologie und Internistische Onkologie
🇩🇪Hamm, NRW, Germany
Universitätsklinikum Essen
🇩🇪Essen, NRW, Germany
MV-Zentrum für Hämatologie und Onkologie
🇩🇪Köln, NRW, Germany
MVZ West GmbH Standort Köln-Kalk
🇩🇪Köln, NRW, Germany
Praxis Internistischer Onkologie und Hämatologie (pioh)
🇩🇪Köln, NRW, Germany
MVZ für Hämatologie und Onkologie
🇩🇪Mülheim an der Ruhr, NRW, Germany
Onkologie Rheinsieg
🇩🇪Troisdorf/Bonn-Beuel/Bad Honnef, NRW, Germany
Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, NRW, Germany
Krankenhaus Bethanien Solingen
🇩🇪Solingen, NRW, Germany
Praxis und Tagesklinik für Internistische Onkologie und Hämatologie
🇩🇪Recklinghausen, NRW, Germany
Onkologie Erzgebirge
🇩🇪Aue-Bad Schlema, Sachsen, Germany
MVZ Medizinisches Versorgungszentrum am Marien-Hospital Wesel
🇩🇪Wesel, NRW, Germany
Medizinisches Versorgungzentrum am Evangelischen Krankenhaus Wesel GmbH
🇩🇪Wesel, NRW, Germany
Fachkrankenhaus Coswig
🇩🇪Coswig, Sachsen, Germany
Hämatologisch Onkologisches Centrum Ostsachsen ONCOS GmbH
🇩🇪Bautzen, Sachsen, Germany
Onkozentrum Dresden/Freiberg/Meißen
🇩🇪Dresden/Freiberg/Meißen, Sachsen, Germany
Gemeinschaftspraxis Dr. med. Johannes Mohm Dr. med. Gabriele Prange-Krex
🇩🇪Dresden, Sachsen, Germany
Gemeinschaftspraxis Hämatologie - Onkologie
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Sachsen, Germany
Ambulante Onkologie Ostsachsen
🇩🇪Zittau, Sachsen, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Thüringen, Germany
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Vivantes Klinikum Neukölln
🇩🇪Berlin, Germany
Onkologische Schwerpunktpraxis Tiergarten
🇩🇪Berlin, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
🇩🇪Berlin, Germany
Praxis am Volkspark
🇩🇪Berlin, Germany
Evangelische Lungenklinik Berlin
🇩🇪Berlin, Germany
DRK Kliniken Berlin Mitte
🇩🇪Berlin, Germany
Helios Klinikum Emil von Behring
🇩🇪Berlin, Germany
Gemeinschaftskrankenhaus Havelhöhe
🇩🇪Berlin, Germany
Onkologischer Schwerpunkt am Oskar-Helene-Heim
🇩🇪Berlin, Germany